MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PSI KIT: 9 FR; INTRODUCER CATHETER

Model Number	IPN036826
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Customer reported "blood backing up into the side port of the introducer with iv fluids infusing into that port.The main line with the hemostasia valve had a swan-ganz catheter in place at that time.Once the swan-ganz was pulled out and that port capped with obturator, the nurse attempted to withdraw blood from side port prior to flushing the line and pulled a 3 inch long blood clot out of the line.".
Event or Problem Description
Customer reported "blood backing up into the side port of the introducer with iv fluids infusing into that port.The main line with the hemostais valve had a swan-ganz catheter in place at that time.Once the swan-ganz was pulled out and that port capped with obturator, the nurse attempted to withdraw blood from side port prior to flushing the line and pulled a 3 inch long blood clot out of the line.".
Additional Manufacturer Narrative
Qn#: (b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW PSI KIT: 9 FR
• Common Device Name: INTRODUCER CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11541620
• Report Number: 9680794-2021-00110
• Device Sequence Number: 4537712
• Product Code: DYB
• UDI-Device Identifier: 10801902117516
• UDI-Public: 10801902117516
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K011761
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: IPN036826
• Device Catalogue Number: AK-29903-CDC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/02/2021
• Supplement Date Received by Manufacturer: 04/13/2021
• Initial Report FDA Received Date: 03/22/2021
• Supplement Report FDA Received Date: 04/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SWAN-GANZ CATHETER; SWAN-GANZ CATHETER